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NCT Number: NCT07397078

Clinical Accuracy Validation of the Moni-Patch Temperature Monitoring Patch System

Moni-Patch Temperature Monitoring Patch System, a non-invasive, continuous temperature monitoring device designed to estimate core body temperature by applying a Sensor to the neck.

This clinical accuracy validation study aims to verify the accuracy and repeatability of the Moni-Patch compared with an FDA-cleared continuous tympanic temperature monitoring device used as the clinical reference.

Main objectives of this study are; To verify that the Moni-Patch and the reference device(tympanic) demonstrate acceptable agreement, as defined by Bland-Altman Analyses (bias within ±0.4°C and limits of agreement between -1.0°C and 1.0°C).

To verify the consistency and repeatability of temperature measurements obtained from the Moni-Patch during continuous monitoring.

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Key information

Conditions

Body Temperature Body Temperature Changes Febrile Fever Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Murata Vios

Woodbury, Minnesota, 55125, United States

About this study

This study is conducted in accordance with ISO 80601-2-56:2017, which outlines definitions for temperature-measuring devices, age groups, required sample sizes, fever definitions, procedural flow, and statistical methods for clinical performance evaluation.

All subjects undergo temperature measurement using the reference device(Tympanic) and the investigational device (Moni-Patch Temperature Monitoring Patch System). The Moni-Patch Sensor is applied to the neck and paired with the Receiver, while the tympanic probe is positioned and sealed in the ear canal.

Each subject participates in a continuous 15-minute temperature monitoring session, during which both devices collect temperature values concurrently every 30 seconds.

Environmental temperature and humidity are also recorded during the session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 7 years
  • Agree to Sensor placement on the neck and ear

Exclusion criteria

  • Ear conditions contraindicating tympanic probe; skin issues at placement sites
  • Antipyretic use within 120 minutes; inability to position neck Sensor over carotid
  • Inability to seal tympanic sensor; tympanic membrane not visually confirmed

Treatment and study plan

Moni-Patch Temperature Monitoring Patch System

Device

Wireless neck-applied Sensor paired with a Receiver via Bluetooth; heat flux and thermistor-based estimation of core temperature; sampling every 30 seconds.

Other names: MP-P20U (Sensor), MP-D20U (Receiver)

Primary outcomes

  1. Agreement between Moni-Patch™ Core Temperature Monitoring Patch System and Continuous Tympanic Temperature (Ttym) Measurements

    Time frame: 15-minute continuous temperature monitoring period following a minimum 30-minute sensor acclimation period (per subject).

    Agreement will be quantified using the mean temperature difference (bias; °C) and Limits of Agreement (LOA; °C) between the Moni-Patch™ Temperature Monitoring Patch System and the comparative FDA-cleared continuous tympanic thermometer (Ttym).

    Paired temperature measurements (Moni-Patch vs. Ttym) collected every 30 seconds during continuous monitoring will be analyzed using Bland-Altman methodology.

    Name of Measurement: Core body temperature difference

    Measurement Tool(s):

    Moni-Patc Temperature Monitoring Patch System FDA-cleared continuous tympanic temperature monitoring device (Ttym)

    Unit of Measure: Degrees Celsius (°C) Analysis Method: Bland-Altman bias and 95% limits of agreement

Study contacts

Contact information is provided by the study sponsor or research team.

Ash Shibata

CONTACT

[email protected]

+1-612-497-7397

Sponsors and collaborators

Lead sponsor

Murata Vios, Inc.

Industry

Collaborators

  • Sonoma State University

Registry information

Official study title

Moni-Patch Temperature Monitoring Patch System Clinical Accuracy Validation

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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